Steroid Need Drops in Crohn's When Biologic Started

75% of patients stop steroids within 6 months

Action Points

Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

ORLANDO -- Corticosteroids are commonly used to reduce inflammatory symptoms in Crohn's disease patients, but their risk of long-term side effects has researchers assessing other options. One such possibility is the use of concomitant corticosteroids with vedolizumab (Entyvio), an integrin antagonist which blocks the movement of white blood cells into the GI tract, researchers reported here.

According to results from a real-world, retrospective cohort analysis of 240 Crohn's patients, one-seventh of those initiating treatment with vedolizumab were treated concurrently with oral corticosteroids.

Use of concomitant corticosteroids, compared with no corticosteroids, was more common among patients who experienced recent Crohn's-related hospitalizations (32.4% versus 18.0%) and had been previously treated with biologics (79.4% versus 70.9%), found Bruce E. Sands, MD, Icahn School of Medicine at Mount Sinai, New York, and colleagues.

Additionally, more than three-fourths of patients who received concomitant corticosteroids did not receive any within 6 months of vedolizumab initiation, Sands reported in a poster session at the 2016 Advances in Inflammatory Bowel Diseases meeting.

Sands and colleagues noted that this research was funded by Takeda, the makers of vedolizumab, which was approved by the FDA for treatment of moderately to severely active Crohn's disease and ulcerative colitis in 2014.

The researchers collected data on adults with Crohn's disease from the Explorys Universe database, which covers approximately 15% of the U.S. population and includes information on electronic health records, outgoing billing, and adjudicated claims.

All patients began vedolizumab from May 1, 2014, to May 18, 2016, and had ≥180 days of follow-up after vedolizumab initiation and at least one year of medical history. The primary corticosteroids of interest were prednisone, budesonide, and hydrocortisone.

The researchers defined concomitant corticosteroid use as having at least two oral corticosteroids prescriptions between 30 days before and 98 days after vedolizumab initiation, including at least one prescription within 30 days of initiation. Successful completion of vedolizumab induction was defined as having at least three infusions within the first 98 days of vedolizumab therapy, as well as a fourth within 90 days after the third.

Sands and colleagues found that a total of 240 patients with Crohn's disease initiated vedolizumab treatment, with 14.2% using concomitant oral corticosteroid. The average age of patients at vedolizumab initiation was 40 years for corticosteroid patients versus 44 years for non-corticosteroid patients, and both groups had a higher number of female patients (58.8% versus 65.5%). The average disease duration since diagnosis was 6.5 versus 6.0 years.

Successful completion of vedolizumab induction in the concomitant corticosteroid group was 67.6% (95% CI 50.8 to 80.9) compared with 65.5% (95% CI 58.8 to 71.7) in the non-corticosteroid group.

According to the authors, a leading study strength was "the use of real-world electronic medical records," which are drawn from multiple centers and "are therefore likely to be more reflective of overall clinical practice than single-center reports."

However, they also listed study limitations, noting that the results for the two cohorts were reported separately, but no statistical testing was performed. They wrote that the outcomes were unadjusted for potential confounding and comparisons should therefore be interpreted with caution.

The study was funded by Takeda and the poster was prepared by Evidera.

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